Medtronic Perfusion Systems recalls Extra corporeal circuit with bio-active surface.
- Recall date
- August 8, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2495-2020
- FDA classification
- Class II
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- Domestic Distribution only to CA and MI.
Why it was recalled
Affected products failed a sterilization test.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Extra corporeal circuit with bio-active surface.
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